Many interview and survey studies can be reviewed as exempt status research. Even though no formal written consent is required for such projects, the IRB will typically require that some kind of informed consent process will occur. That process would typically involve a short information sheet, for a focus group or interview study, or asking subjects to read a short introductory paragraph in a survey study.
The key word here is “short.” This written information should be brief, to the point, and cover only what the subject needs to know about the research. It does NOT need to contain all the usual consent requirements, so we strongly advise against trying to adapt a full-blown study consent form for use in one of these exempt status studies.
The essentials to be addressed are typically:
- That you are being asked to join a research study
- The purpose of the study
- What participation would entail and how long it will take
- A description of measures taken to protect data confidentiality (specifically address whether any identifying information will be collected)
- Who might see the data
- Participation is voluntary, and nothing about their medical care/student or employee status will change as a result of whatever decision they make
- Contact information for the PI and the IRB.
And that’s it. The best information sheets are maybe two paragraphs long, at most. Many interview, focus group, and survey studies can be completed rather quickly and/or involve developing a certain rapport with participants, and an overly long and potentially confusing sheet with information not relevant to the study at hand may discourage rather than encourage participation.